Prospective randomised double masked trial of monofocal, multifocal and accommodative intraocular lens
| ISRCTN | ISRCTN08342378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08342378 |
| Protocol serial number | N0388119782 |
| Sponsor | Department of Health (UK) |
| Funder | The Hillingdon Hospital (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 04/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Phillip Bloom
Scientific
Scientific
The Hillingdon Hospital
Pield Health Road
Hillingdon
UB8 3NN
United Kingdom
| Phone | +44 (0)1895 238282 |
|---|---|
| phillip.bloom@thh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | How effective are accommodating intraocular lens in comparison with monofocal and multifocal lens for patients having undergone cataracts removal? |
| Ethics approval(s) | Ethical approval for the trial was obtained from the local hospital ethics committee prior to commencement. |
| Health condition(s) or problem(s) studied | Cataract |
| Intervention | Patients underwent bilateral sequential phacoemulsification with implantation of one of the three IOL types: 1. Accommodative IOL 2. A multifocal IOL 3. A monofocal IOL (control group) Patients were assessed at 3 and 18 months after second-eye surgery. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 69 |
| Key inclusion criteria | Patients undergoing cataract surgery who are: 1. Greater than 18 years old 2. Bilateral visually significant cataracts with extraction indicated 3. Informed consent 4. Ability to understand and complete TyPE questionnaire |
| Key exclusion criteria | 1. Macular or other pathology considered likely to limit post-operative acuity to worse than 6/9 in either eye 2. Corneal astigmatism greater than 1.5 dioptres in either eye 3. Required IOL power outside range available for multifocal IOL (16 - 24 dioptres) |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 01/02/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Hillingdon Hospital
Hillingdon
UB8 3NN
United Kingdom
UB8 3NN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2008 | Yes | No |
